Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma

Status:	Completed
Conditions:	Blood Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/24/2018
Start Date:	December 28, 2011
End Date:	January 17, 2017

A Phase 2 Biomarker Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) Monotherapy to Assess the Association Between NK Cell Status and Efficacy in High Risk Smoldering Myeloma

The purpose of this study is to determine whether elotuzumab will improve response in
patients with high risk smoldering myeloma who have more CD56^dim cells (a marker for the
health of the body's immune system)

Intervention model: Dosing is sequential

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Key Inclusion Criteria:

Participants with a confirmed diagnosis, according to criteria of the International Myeloma
Working Group, of smoldering multiple myeloma, considered high risk according to the
following:

- Serum monoclonal (M) protein ≥3 gm/dL and bone marrow plasma cells (BMPC) ≥10% or

- Serum M protein 1-3 g/dL and BMPC ≥10% and abnormal free light chain ratio of <0.125
or >8.0

- Urine M protein >200 mg/24 hours, ≥10% BMPC, and serum free light chain ratio ≤0.125
or ≥8.0

Key Exclusion Criteria:

- Active multiple myeloma

- Monoclonal gammopathy of undetermined significance

- Active plasma cell leukemia

- Positive for hepatitis B or C virus or HIV infection

We found this trial at

sites

Dana-Farber Cancer Institute

450 Brookline Ave
Boston, Massachusetts 2215

617-632-3000